ICD Archives - Medical Design Sourcing

Study: Medtronic ICDs can help prevent sudden cardiac death

The Aurora EV-ICD with the lead. [Image courtesy of Medtronic]Medtronic (NYSE: MDT) + today announced data demonstrating improved outcomes with its implantable cardioverter defibrillators (ICDs).

ICDs treat dangerously fast or irregular heart rhythms — ventricular tachycardia or ventricular fibrillation — that can lead to sudden cardiac death (SCD).

Two analyses demonstrated survival benefits nad a reduction in life-threatening cardiac events with the use of ICDs. Data provided real-world evidence supporting the use of Medtronic ICDs for indicated patients. Dr. Angelo Auricchio presented the results at the European Society of Cardiology (ESC) Congress in Amsterdam. Auricchio, the lead author of both analyses, serves as deputy head of cardiology and director of the clinical electrophysiology unit at Fondazione Cardiocentro Ticino in Lugano, Switzerland.

One retrospective analysis demonstrated an association of ICDs …

The flaw that likely caused Medtronic’s massive ICD and CRT-D recall — and why they’re too risky to replace

Medtronic has recalled implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators that may fail to deliver life-saving shocks for cardiac patients. [Photo courtesy of Medtronic]

Medtronic identified a likely design flaw that can cause defibrillator implants to halt life-saving shocks for cardiac patients.

An insulation defect appears to be to blame for Medtronic’s massive Class I recall of implantable cardioverter defibrillators (ICDs), including cardiac resynchronization therapy defibrillators (CRT-Ds).

The FDA said it has not yet determined a cause and that Medtronic is investigating. But Medtronic — the world’s largest medical device manufacturer — identified the likely problem in an urgent medical device correction notice sent to healthcare providers.

Medtronic identified 348,616 devices in the U.S. for the recall, distributed from Oct. 13, 201…

Medtronic has a serious recall of ICDs and CRT-Ds

FDA has issued a Class I designation of a Medtronic (NYSE: MDT) recall involving 239,171 ICDs and CRT-Ds with potential battery life problems.

The agency reported 444 complaints regarding the devices: Evera, Viva, Brava, Claria, Amplia, Compia, and Visia implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy (CRT-Ds) distributed from Aug. 31, 2012, to May 9, 2018.

Among 264 Medical Device Reports, there were 18 injuries, including people experiencing bradycardia (slow heart rhythm) or heart failure symptoms. There were no reports of deaths.

The devices’ problem involves a potential short circuit that could cause an unexpected and rapid decrease in battery life. The time between the first “Recommended Replacement Time” warning and full battery depletion could be as little as one day. However, a Medtronic spokesperson noted to MassDevice that the median time from RRT to end of service was 14 days.

Medtronic is no…